Study of the Bria-IMT Regimen and CPI vs Physicians' Choice in Advanced Metastatic Breast Cancer.

NCT06072612 | Recruiting Phase 3 DMC FDA Drug

• 1 other identifier: BC-IMT-04
• Study Type: interventional
• Target: 404
• Locations: 1 country
• Sites: 78

Brief Summary

This is a multicenter randomized, open label study to evaluate overall survival with the Bria-IMT regimen in combination with Checkpoint Inhibitor \[Retifanlimab\], versus Treatment of Patients'/Physicians' Choice (TPC) in advanced metastatic or locally recurrent breast cancer (aMBC) patients with no approved alternative therapies available.

Conditions

Breast Cancer; Metastatic Breast Cancer; Breast Neoplasm; Breast Cancer Metastatic; End Stage Cancer

Keywords

Breast; metastatic; advanced; cancer; late line

Outcome Measures

Primary Outcomes (1)

• Overall Survival

  To evaluate the effect of the Bria-IMT regimen in combination with Check Point Inhibitor (CPI) on overall survival (OS) compared to treatment of physician's choice (TPC) chemotherapy in patients with metastatic breast cancer with no approved alternative therapies available as per the Inclusion criteria.

  Up to 60 months

Secondary Outcomes (5)

• Progression-free survival (PFS)

  Up to 60 months

• Clinical Benefit Rate (CBR)

  Up to 60 months

• Overall response rate (ORR)

  Up to 60 months

• Quality of life (QoL)

  Up to 60 months

• CNS Event free survival (EFS)

  Up to 60 months

Study Arms (3)

Bria-IMT Regimen + CPI

EXPERIMENTAL

The Bria-IMT regimen: Day -2 or -3 Cyclophosphamide 300mg/m2 Day 0 SV-BR-1-GM given intradermally divided into 4 inoculations Day 1-3 CPI infusion plus interferon administered intra-dermally within each SV-BR-1-GM inoculation site

Biological: SV-BR-1-GM; Drug: Cyclophosphamide; Drug: Interferon infiltration of the inoculation site; Drug: Retifanlimab

Treatment of Physician's Choice

ACTIVE COMPARATOR

TPC consists of eribulin, carboplatin, capecitabine, gemcitabine, vinorelbine or taxanes in accordance with the investigators' and institutional standard of care. The specific details of the selected regimen must include every detail of administration including frequency, sequencing (for multi-agent regimens), duration of infusion or oral administration, planned dose, dose prescribed, dose administered, dose adjustments after initial prescription or start of TPC treatment, and any other change in TPC from its initial election prior to randomization.

Drug: Treatment of Physician's Choice

Bria-IMT Regimen Alone

EXPERIMENTAL

The Bria-IMT regimen: Day -2 or -3 Cyclophosphamide 300mg/m2 Day 0 SV-BR-1-GM given intradermally divided into 4 inoculations Day 1-3 CPI infusion plus interferon administered intra-dermally within each SV-BR-1-GM inoculation site

Biological: SV-BR-1-GM; Drug: Cyclophosphamide; Drug: Interferon infiltration of the inoculation site

Interventions

SV-BR-1-GM BIOLOGICAL

SV-BR-1-GM is an experimental, allogeneic, whole cell breast tumor cell line stably transfected with the CSF2 gene (encoding GM-CSF) to secrete GM-CSF in vivo to consequently augment dendritic cell activity

Also known as: Part of the Bria-IMT regimen

Bria-IMT Regimen + CPI; Bria-IMT Regimen Alone

Cyclophosphamide DRUG

Cyclophosphamide is an alkylating agent with indications for treatment of malignant diseases including breast cancer. Cyclophosphamide (Cytoxan) 300 mg/m2 I.V., single dose, will be given to patients assigned to the SV-BR-1-GM. Cyclophosphamide will be administered 2-3 days prior to SV-BR-1-GM inoculations.

Bria-IMT Regimen + CPI; Bria-IMT Regimen Alone

Interferon infiltration of the inoculation site DRUG

Interferon is a cytokine released by cells to regulate immune responses to viral infections. For this study, 0.1 mcg Pegasys per injection site (x 4 injection sites) will be administered.

Bria-IMT Regimen + CPI; Bria-IMT Regimen Alone

Retifanlimab DRUG

Retifanlimab is a checkpoint inhibitor. A total dose of 375mg will be administered at first cycle on or about day +2 (+/-1d). In all other cycles, Retifanlimab is permitted to be administered between Day -2/-3 to Day 2±1 of the cycle based on the convenience of the patients and the clinical sites. However once the timing of the CPI is chosen for C1, it must be given on the same day thereafter throughout the trial.

Bria-IMT Regimen + CPI

Treatment of Physician's Choice DRUG

Patients in the TPC arm of the study will be treated with one or a combination of the following: carboplatin, taxanes, capecitabine, gemcitabine, vinorelbine or eribulin in accordance with the investigators and institutional standard of care. For HER2+ patients, a HER2-targeted agent of the physician's choice can be part of TPC.

Treatment of Physician's Choice

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Be ≥ 18 years of age.
• Have signed informed consent.
• Have histological confirmation of breast cancer with either locally recurrent unresectable and/or metastatic lesions, and have failed prior therapy:
• Patients with persistent disease and local recurrence must not be amenable to local treatment.
• For patients with metastatic disease, late-stage MBC with no meaningful alternative therapies available and the following class specific treatment histories:
• Human epidermal growth factor 2 (HER2) positive must be previously treated with at least 3 regimens containing at least two anti-HER2 and at least one chemotherapy containing regimen.
• Estrogen receptor (ER), progesterone receptor (PR) positive tumors: must be refractory to hormonal therapy demonstrated by progression on at least 2 hormonal agents in 2 separate lines of hormone directed therapy.
• Triple Negative tumors: Must have exhausted all curative intent therapies including at least 2 prior chemotherapy regimens, which can include regimens in neoadjuvant and adjuvant settings.
• Cancers with known germline or genomic actionable targets, e.g. g/mBRCA, must have been treated with all tumor directed indicated treatment e.g. PARPi, if tolerated.
• HER2 low patients, in addition to the appropriate therapies based on ER/PR status and germline or genomic actionable targets, must also have received at least one HER2-targeted agent approved for treatment of HER2 low patients.
• HER2 negative tumors must be refractory to hormonal therapy (if indicated) and previously treated with at least 2 chemotherapy regimens.
• Patients with new or progressive breast cancer metastatic to the brain will be eligible provided:
• The brain metastases must be clinically stable (without evidence of progressive disease by imaging for at least 4 weeks prior to first dose)
• There is no need for steroids and patients have not had steroids for at least 2 weeks prior to the first dose
• Tumor is not impinging on Middle Cerebral Artery/speech-motor strip

You may not qualify if:

• Concurrent or recent chemotherapy, immunotherapy or major surgery within 21 days prior to the first dose.
• Radiotherapy within 14 days of the first dose of study treatment.
• Toxicity of prior therapy that has not recovered to ≤ Grade 1 or baseline (with the exception of any grade of alopecia and anemia not requiring transfusion support).
• Any toxicity to prior CPI that was grade 3 or higher unless it has been successfully treated (e.g. hypothyroidism or hypopituitarism treated with replacement therapy), .
• Toxicity to prior CPI that has not resolved to grade 1 or less except for stable asymptomatic endocrinopathies.
• History of clinical hypersensitivity to the designated therapy as specified in the protocol, including the proposed TPC, beef, or to any components used in the preparation of SV- BR-1-GM.
• History of hypersensitivity to any of the therapies proposed for treatment in this study.
• Serum creatinine OR Measured OR calculated Creatinine Clearance (CrCl) (GFR can also be used in place of creatinine or CrCl) \>2.0 × ULN or \<30 mL/min for participants with creatinine levels \>2.0 × institutional ULN.
• Absolute granulocyte count \<1000; platelets \<80,000; hemoglobin ≤ 7 g/L.
• INR or PT or aPTT \> 1.8 × ULN, unless the participant is receiving anticoagulant therapy as long as PT or aPTT is within therapeutic range of intended use of anticoagulants.
• Receiving any medication listed in the prohibited medication section of the protocol.
• Proteinuria \>2+ on urinalysis
• A history or presence of an abnormal electrocardiogram (ECG) that, in the Investigator's opinion, is clinically meaningful. Screening corrected QT interval (QTc) interval \>480 milliseconds is excluded (corrected by Fridericia or Bazett formula). In the event that a single QTc is \>480 milliseconds, the participant may enroll if the average QTc for the 3 ECGs is \<480 milliseconds.
• New York Heart Association stage 3 or 4 cardiac disease.
• A pericardial effusion of moderate severity or worse.

Sponsors & Collaborators

• BriaCell Therapeutics Corporation: lead

Study Sites (78)

Mayo Clinic-Comprehensive Cancer Center-Breast Clinic

Phoenix, Arizona, 85054, United States

RECRUITING

University of Arizona-Cancer Center

Tucson, Arizona, 85719, United States

RECRUITING

Los Angeles cancer Network_Anaheim

Anaheim, California, 92801, United States

RECRUITING

Comprehensive Blood and Cancer Center

Bakersfield, California, 93309, United States

RECRUITING

Cedars-Sinai Cancer Beverly Hills

Beverly Hills, California, 90211, United States

RECRUITING

Los Angeles Cancer Network_Corona

Corona, California, 92879, United States

RECRUITING

Los Angeles cancer Network_Fountain Vallley

Fountain Valley, California, 92708, United States

RECRUITING

Los Angeles Cancer Network_Glendale

Glendale, California, 91206, United States

RECRUITING

Hoag Hospital Center

Irvine, California, 92618, United States

RECRUITING

Hoag Hospital Irvine

Irvine, California, 92618, United States

RECRUITING

Los Angeles Cancer Network

Los Angeles, California, 90017, United States

RECRUITING

Cedars-Sinai Cancer at Cedars-Sinai Medical Facility

Los Angeles, California, 90048, United States

RECRUITING

Los Angeles Cancer Network_Century City

Los Angeles, California, 90067, United States

RECRUITING

UCLA-Hematology/Oncology Medical Plaza

Los Angeles, California, 90095, United States

RECRUITING

UCLA-Hematology/Oncology_LA 2

Los Angeles, California, 90095, United States

RECRUITING

UCLA-Hematology/Oncology_LA

Los Angeles, California, 90095, United States

RECRUITING

Los Angeles Cancer Network_Pasadena

Pasadena, California, 91105, United States

RECRUITING

Los Angeles cancer Network_Riverside

Riverside, California, 92501, United States

RECRUITING

UC San Diego

San Diego, California, 92037, United States

RECRUITING

St. John's Cancer Center

Santa Monica, California, 90404, United States

RECRUITING

UCLA-Department of Medicine Hematology/Oncology-Parkside

Santa Monica, California, 90404, United States

RECRUITING

UCLA-Hetamtology/Oncology_S Monica

Santa Monica, California, 90404, United States

RECRUITING

Torrance Memorial Cancer Center

Torrance, California, 90505, United States

RECRUITING

Los Angeles Cancer Network_Valley Pres

Van Nuys, California, 91405, United States

RECRUITING

Cedars-Sinai Breast Health Services Building

West Hollywood, California, 90048, United States

RECRUITING

Smilow Cancer Hospital at Yale New Haven

New Haven, Connecticut, 06511, United States

RECRUITING

University of Miami _SCCC - Aventura

Aventura, Florida, 33180, United States

RECRUITING

University of Miami-SCCC-Lennar

Coral Gables, Florida, 33146, United States

RECRUITING

University of Miami_SCCC-Coral Springs

Coral Springs, Florida, 33065, United States

RECRUITING

University of Miami Hospital and Clinics - Deerfield Beach

Deerfield Beach, Florida, 33442, United States

RECRUITING

University of Miami_SCCC-Hollywood

Hollywood, Florida, 33021, United States

RECRUITING

Mayo Clinic Florida-Comprehensive Cancer Center

Jacksonville, Florida, 32224, United States

RECRUITING

University Of Miami-SCCC-Miami

Miami, Florida, 33136, United States

RECRUITING

University of Miami_SCCC - Kendall

Miami, Florida, 33176, United States

RECRUITING

Advent Health - Orlando

Orlando, Florida, 32804, United States

RECRUITING

University of Miami-SCCC-Plantation

Plantation, Florida, 33324, United States

RECRUITING

Winship Cancer Institute of Emory University

Atlanta, Georgia, 30322, United States

RECRUITING

Northwestern University

Chicago, Illinois, 60611, United States

RECRUITING

Southern Illinois University-Simmons

Springfield, Illinois, 62702, United States

RECRUITING

Carle Foundation Cancer Institute-Urbana

Urbana, Illinois, 61801, United States

RECRUITING

Northwest Cancer Center

Dyer, Indiana, 46311, United States

RECRUITING

AMR Kansas City Oncology

Kansas City, Kansas, 66204, United States

RECRUITING

Care Access-Marrero

Marrero, Louisiana, 70072, United States

RECRUITING

The Center for Cancer and Blood Disorders a division of American Oncology Partners, P.A.

Bethesda, Maryland, 20817, United States

RECRUITING

Mayo Clinic-Comprehensive Cancer Center-Breast Clinic

Rochester, Minnesota, 55905, United States

RECRUITING

Nebraska Cancer Specialists

Omaha, Nebraska, 68130, United States

RECRUITING

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

RECRUITING

Hunterdon Medical Center

Flemington, New Jersey, 08822, United States

RECRUITING

New York Cancer and Blood Specialists_North Shore Hematology Oncology Assocaites P.C. (Babylon)

Babylon, New York, 11702, United States

RECRUITING

New York Cancer and Blood Specialists_North Shore Hematology Oncology Assocaites P.C.(New Hyde Park)

New Hyde Park, New York, 11042, United States

RECRUITING

Manhattan Hematology /Oncology Associates

New York, New York, 10016, United States

RECRUITING

New York Cancer and Blood Specialists_North Shore Hematology Oncology Assocaites P.C (NY)

New York, New York, 10028, United States

RECRUITING

New York Cancers & Blood Specialists_North Shore Hematology Oncology Assocaites P.C (Patchogue)

Patchogue, New York, 11772, United States

RECRUITING

New York Cancer and Blood Specialists_North Shore Hematology Oncology Assocaites P.C. (Port Jefferson Station2)

Port Jefferson Station, New York, 11776, United States

RECRUITING

New York Cancer and Blood Specialists_North Shore Hematology Oncology Assocaites P.C.(Port Jefferson Station1)

Port Jefferson Station, New York, 11776, United States

RECRUITING

New York Cancers & Blood Specialists

Port Jefferson Station, New York, 11776, United States

RECRUITING

New York Cancer and Blood Specialists_North Shore Hematology Oncology Assocaites P.C. (Riverhead)

Riverhead, New York, 11901, United States

RECRUITING

New York Cancer and Blood Specialists_North Shore Hematology Oncology Assocaites P.C (Brox)

The Bronx, New York, 10469, United States

RECRUITING

Regional Medical Oncology Center_Wlson

Wilson, North Carolina, 27893, United States

RECRUITING

Gabrail Cancer & Research Center

Canton, Ohio, 44718, United States

RECRUITING

Cleveland Clinic

Cleveland, Ohio, 44195, United States

RECRUITING

Texas Oncology-Baylor Charles A. Sammons Cancer Center

Dallas, Texas, 75246, United States

RECRUITING

Mary Crowley Cancer Research

Dallas, Texas, 75251, United States

RECRUITING

DHR Health Oncology Institute

Edinburg, Texas, 78539, United States

RECRUITING

Texas Oncology - Fredericksburg

Fredericksburg, Texas, 78624, United States

RECRUITING

Texas Oncology - Harlingen

Harlingen, Texas, 78550, United States

RECRUITING

Texas Oncology McAllen

McAllen, Texas, 78503, United States

RECRUITING

Texas Oncology, New Braunfels

New Braunfels, Texas, 78130, United States

RECRUITING

Texas Oncology-San Antonio Cancer Care

San Antonio, Texas, 78216, United States

RECRUITING

Texas Oncology - San Antonio Northeast

San Antonio, Texas, 78217, United States

RECRUITING

Texas Oncology - San Antonio Stone Oak

San Antonio, Texas, 78258, United States

RECRUITING

Tranquil Clinical Research

Webster, Texas, 77598, United States

RECRUITING

Texas Oncology - Weslaco

Weslaco, Texas, 78596, United States

RECRUITING

Hematology-Oncology Associates of Fredericksburg, Inc

Fredericksburg, Virginia, 22408, United States

RECRUITING

Cancer Care Northwest-1 (601 S. Sherman)

Spokane, Washington, 99202, United States

RECRUITING

Cancer Care Northwest_2 (605 E. Holland)

Spokane, Washington, 99218, United States

RECRUITING

Cancer Care Northwest

Spokane Valley, Washington, 99218, United States

RECRUITING

Sheboygan Cancer & Blood Specialists

Sheboygan, Wisconsin, 53081, United States

RECRUITING

Related Links

• Sponsor
• CRO

MeSH Terms

Conditions

Breast Neoplasms; Neoplasm Metastasis; Neoplasms

Interventions

Cyclophosphamide

Condition Hierarchy (Ancestors)

Neoplasms by Site; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds

Study Officials

• Giuseppe Del Priore, MD MPH

  BriaCell Therapeutics

  STUDY DIRECTOR

Central Study Contacts

Sue Torchio, CPM

CONTACT

267-797-2061; sue.torchio@PrevailinfoWorks.com

Marcela Salgado, MD

CONTACT

1-888-309-1868; MSalgado@briacell.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 25, 2023
• First Posted: October 10, 2023
• Study Start: December 5, 2023
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): June 1, 2028
• Last Updated: April 2, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (78)